Proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

Author (Corporate)
Series Details COM (2020) 725
Publication Date 11/11/2020
Content Type ,

Summary:

Legislative initiative tabled by the European Commission on 11 November 2020, aimed at extending the mandate of the European Medicines Agency (EMA).

Further information:

The COVID-19 (coronavirus) pandemic highlighted the limited ability of the European Union (EU) to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development. It became clear that the EMA requires a framework to be deployed in preparation for and during public health emergencies and other major events to improve the EU's capacity to react quickly, efficiently, and in a coordinated manner to such emergencies. The general objectives of the legislative proposal are to:

  1. ensure a high level of human health protection by strengthening the Union’s ability to manage and respond to public health emergencies, which have an impact on medicinal products and medical devices;
  2. contribute to ensuring the smooth functioning of the internal market for such products during public health emergencies.

It was tabled by the European Commission on 11 November 2020, alongside a Communication setting out the first elements of a European Health Union. The Council of the European Union adopted its general approach on 15 June 2021, followed by the plenary of the European Parliament on 8 July.

Source Link https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2020:725:FIN
Related Links
Commentary and Analysis
European Patients Forum: Public consultation on European Medicines Agency – strengthened role to address public health emergencies (31 January 2021) https://www.eu-patient.eu/globalassets/0.-epf-consultation-response---ema_final.pdf
AESGP: Position Paper, 04/02/2021: Position on a reinforced EMA mandate (European Health Union) https://aesgp.eu/articles/position-on-a-reinforced-ema-mandate-european-health-union
BEUC: Position Paper, 12/04/2021: A More Powerful EMA to Better Protect Consumers in Crisis Times https://www.beuc.eu/publications/beuc-x-2021-033_a_more_powerful_ema_to_better_protect_consumers_in_crisis_times.pdf
EPRS: At a Glance, July 2021: European Medicines Agency mandate extension https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_ATA(2021)690694
BEUC: Press Release, 08/07/2021: EU Parliament supports reinforced role for European Medicines Agency in benefit to consumers https://www.beuc.eu/publications/eu-parliament-supports-reinforced-role-european-medicines-agency-benefit-consumers/html

News
EurActiv, 16/06/2021: EU health ministers back stronger pandemic role for EMA https://www.euractiv.com/section/eu-council-presidency/news/eu-health-ministers-back-stronger-pandemic-role-for-ema/

Official
European Parliament: Legislative Observatory: Procedure File for Proposal on European Medicines Agency (2020/0321(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2020/0321(COD)
European Parliament: Legislative Train Schedule: Extension of the mandate of the European Medicines Agency (EMA) https://www.europarl.europa.eu/legislative-train/theme-promoting-our-european-way-of-life/file-ema-mandate-extension
Official Website of the European Medicines Agency https://www.ema.europa.eu/en
European Commission: Priorities 2019-2024: European Health Union https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
General Secretariat of the Council: Policies: Protecting Europeans against cross-border health threats https://www.consilium.europa.eu/en/policies/protecting-against-cross-border-health-threats/
European Commission: Press Release, 11/11/2020: Building a European Health Union: Stronger crisis preparedness and response for Europe https://ec.europa.eu/commission/presscorner/detail/en/ip_20_2041
European Commission: Questions and Answers: Building a European Health Union: Stronger crisis preparedness and response for Europe (11 November 2020) https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2042
European Commission: Remarks by Commissioner Stella Kyriakides at the press conference on Building a European Health Union (11 November 2020) https://ec.europa.eu/commission/presscorner/detail/en/speech_20_2090
Council of the European Union: Press Release, 15/06/2021: Council agreement paves way to reinforce European Medicines Agency https://www.consilium.europa.eu/en/press/press-releases/2021/06/15/council-agreement-paves-way-to-reinforce-european-medicines-agency/
European Parliament: Press Release, 22/06/2021: COVID-19 lessons learned: stronger role for EU medicines regulator https://www.europarl.europa.eu/news/en/press-room/20210617IPR06466/
S&D Group: Newsroom, 22/06/2021: S&Ds: a stronger European Medicine Agency brings the creation of a Health Union closer https://www.socialistsanddemocrats.eu/newsroom/sds-stronger-european-medicine-agency-brings-creation-health-union-closer
European Parliament: Press Release, 08/07/2021: Reinforcing the mandate for EU medicines regulator https://www.europarl.europa.eu/news/en/press-room/20210701IPR07513/

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